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A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02158533
Recruitment Status : Completed
First Posted : June 9, 2014
Results First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.

Tracking Information
First Submitted Date  ICMJE June 5, 2014
First Posted Date  ICMJE June 9, 2014
Results First Submitted Date  ICMJE March 1, 2019
Results First Posted Date  ICMJE March 27, 2019
Last Update Posted Date March 27, 2019
Study Start Date  ICMJE May 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
Change From Baseline to Week 5 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score [ Time Frame: 5 weeks for each stage ]
The MADRS-10 scale is a clinician-administered questionnaire comprised of 10 items used to measure the severity of MDD symptoms. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms). Individual questionnaire items include: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts.
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
Change from baseline in the Montgomery Asberg Depression Rating Scale (MADRS) total score [ Time Frame: 11 weeks ]
Change History Complete list of historical versions of study NCT02158533 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2019)
  • Response Rate [ Time Frame: 5 weeks for each stage ]
    The proportion of subjects demonstrating MADRS-10 treatment response, defined as a >/= 50% reduction in MADRS-10 score from baseline to the end of the efficacy period (Week 5). The MADRS-10 scale is a measure of the severity of MDD symptoms and includes the following 10 items: Apparent Sadness, Reported Sadness, Inner Tension, Reduced Sleep, Reduced Appetite, Concentration Difficulties, Lassitude, Inability to Feel, Pessimistic Thoughts, and Suicidal Thoughts. Scores range from 0 (no apparent symptoms) to 60 (most severe symptoms).
  • Remission Rate [ Time Frame: 5 weeks for each stage ]
    The proportion of subjects achieving remission, defined as a MADRS-10 score of </= 10 at the end of the efficacy period.
  • Adverse Events (AEs) [ Time Frame: 5 weeks for Stage 1 and 6 weeks for Stage 2 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2014)
  • Response during randomized treatment [ Time Frame: 11 weeks ]
    Based on pre-specified decrease of MADRS total score
  • Remission during randomized treatment [ Time Frame: 11 weeks ]
    Based on pre-specified MADRS total score
  • Safety and tolerability will be assessed by number and percentage of subjects with adverse events (AEs) [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - the FORWARD-4 Study
Official Title  ICMJE A Phase 3 Efficacy and Safety Study of ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder (the FORWARD-4 Study)
Brief Summary This study will evaluate the efficacy and safety of ALKS 5461.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: High Dose ALKS 5461
    Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
    Other Name: ALKS 5461
  • Drug: Low Dose ALKS 5461
    Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
    Other Name: ALKS 5461
  • Drug: Placebo
    Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Study Arms  ICMJE
  • Experimental: High Dose
    Intervention: Drug: High Dose ALKS 5461
  • Experimental: Low Dose
    Intervention: Drug: Low Dose ALKS 5461
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2016)
385
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2014)
350
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have a Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive
  • Agree to use an acceptable method of contraception for the duration of the study
  • Have a Major Depressive Disorder (MDD) primary diagnosis
  • Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the current Major Depressive Episode (MDE)
  • Additional criteria may apply

Exclusion Criteria:

  • Have a current primary Axis-I disorder other than MDD
  • Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid antagonists (eg, naloxone, naltrexone) within 14 days
  • Have received electroconvulsive therapy treatment within the last 2 years or received more than one course of electroconvulsive treatment during lifetime
  • Have attempted suicide within the past 2 years
  • Have a positive test for drugs of abuse
  • Are pregnant, planning to become pregnant, or breastfeeding
  • Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
  • Have had a significant blood loss or blood donation within 60 days
  • Additional criteria may apply
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02158533
Other Study ID Numbers  ICMJE ALK5461-205
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alkermes, Inc.
Study Sponsor  ICMJE Alkermes, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sanjeev Pathak, MD Alkermes, Inc.
PRS Account Alkermes, Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP